Quality Control Tests

of Capsules
Dr. Samar Mohamed Alsousi
 Capsules: are solid dosage forms in which the drug substance is
enclosed within either a hard or soft soluble shell, usually formed
from gelatin. The term capsule is derived from the Latin word
capsula, meaning a small container.
 Two type of capsule :
 Hard gelatin capsules: are also known as dry-filled capsules or
two piece capsules. Hard gelatin capsule consists of two parts
known as capsule body (longer part) and the capsule cap (the
shorter part) The drug substance placed in the body and the
caps are slided over it, hence enclosing the drug substance.
 Soft gelatin capsules: It is a solid capsule surrounding a liquid
or semisolid center. AI can be incorporated in the outer shell,
inner fill or both. Shells of the SGC are combination of gelatin,
water, plasticizers and additional ingredients.
Quality Control Tests of Capsules

 Weight variation test

 Content uniformity test
 Disintegration test
 Dissolution test
 Sealing test
 Microbial test
 Weight Variation Test

For Hard Gelatin Capsules:

 Weigh 20 capsules individually and determine the avg. weight
 The individual weights should be with in limit of 90-110% of avg.
wt.
 If not all of capsules fall within the limits, Weigh 20 capsules
individually.
 Remove the net content of each capsule with the aid of a small
brush.
 Weigh the empty shells individually.
Net wt. of contents individually = gross wt - the wt. of shell.
 Weight Variation Test
 LIMITS:
 Not more than 2 of the differences are greater than 10% of
the avg. net content.
 No case is the difference greater then 25% wt. range.
If more than 2, but not more than 6 capsules deviate from the avg.
but within 10-25%, Determine the net contents of an additional 40
capsules, Determine the avg. content of entire 60 capsules,
Determine the 60 deviations from the new avg.
 LIMITS:
 Not more than 6 of 60 capsules does the difference exceed
10% of the avg. net content.
 No case does the difference exceed 25%.
 Weight Variation Test

For Soft Gelatin Capsules

 Proceed as directed under hard capsules, but determine the net

wt. of the contents of individual capsules as follows:
 Weigh the capsules individually then cut and open the capsules
 Remove the contents by washing with the suitable solvent (that
dissolves the fill but not the shell).
 Allow the solvents to evaporate from the shells at room temp.
 Weigh the individual shells.
 Calculate the net contents.
 Content Uniformity Test

 In this case, 30 capsules are selected, 10 of which are assayed by

the specified procedure. The requirements are met if 9 of the 10
are within the specified potency range of 85 to 115 %, and the
tenth is not outside 75 to 125 %.

 If more than 1, but less than 3, of the first 10 capsules fall out
side the 85 to 115 % limits, the remaining 20 are assayed. The
requirements are met if all 30 capsules are with in 75 to 125 % of
the specified potency range, and not less than 27 of the 30 are
within the 85 to 115% range.
 Disintegration Test

 Disintegration test apparatus is used.

 One capsule is placed in each tube which are suspended in
the beakers to move up and down for 30 minutes.
 The capsules pass the test if no drug or fragments of the
shell remains on the 10-mesh.
 Dissolution Test

 The dissolution test is carried out using the dissolution apparatus

official in both the U.S.P and B.P.
 The capsule is placed in a basket, and the basket is immersed in
the dissolution medium and caused to rotate at a specified speed.
 The dissolution medium is held in a covered 1000ml glass vessel
and maintained at 370C + 0.50C by means of a constant
temperature suitable water bath.
 The stirrer speed and type of dissolution medium are specified in
the individual monograph.
 Normally, shell ruptures and dissolves within about 4 minutes.
 Rupture occurs first at the shoulders where shell wall is thinnest.
 Basket apparatus and (UV-VIS) Spectroscopy
to test cephalexin dissolution:
 Perform dissolution test for Keflex®(cephalexin) 500 mg
 Dissolution parameters :
 Medium (H2O)
 Volume (900mL)
 Apparatus (basket)
 Speed (100 rpm)
 Time (30 min)
 ƛ max (262 nm)
 Q tolerance (80%)
Lab Calculation
Amount of A.I in 2.5ml
 500mg (tab) ---- 900ml(DW) given = actual
abs
?? ---- 2.5ml

For stock sol. should have the same amount of A.I in 2.5ml
 0.1g --- 100ml(DW)
?? --- ?? (ml) given = standard
abs

 Q” tolerance = actual abs./standard abs. *100%

** Q” tolerance: the amount of AI dissolved in solvent 900ml

Dissolution test results and
interpretation
Sealing Test
 Soft gelatin capsules are tested for physical integrity
(absence of leakage) by visual inspection.
 Similarly, hard gelatin capsules are tested for any breach
of physical integrity (breakage or opened cap and body).
 Microbial Content
 The capsules are tested to ensure lack of growth of bacteria and
mould by microbiological tests.
 These tests are usually carried out by incubation of the capsule
contents in a growth medium and counting the colonies formed
after a predefined period of time.
 Selection of the growth medium and duration of the test, as well
as maintenance of aseptic conditions during the testing, are
critical to successful assessment of microbial contamination by
this method.